study design

March 30, 2020: New Living Textbook Chapter Describes Ways to Monitor Intervention Fidelity and Adaptations During the Conduct of ePCTs

Posted on by Gina Uhlenbrauck

The new Monitoring Intervention Fidelity and Adaptations chapter of the Living Textbook was developed to introduce how to evaluate changes that may be encountered while conducting an embedded pragmatic clinical trial (ePCT). For example, a health system might experience competing clinical initiatives; turnover in leadership, clinicians, or staff; changes in technologies; new clinical practice guidelines; or regulatory changes.

The chapter offers strategies for study teams to anticipate, monitor, and document adaptations to the intervention in order to support study analysis and set the stage for dissemination and implementation of successful interventions in other healthcare settings. The chapter was developed by experts from the Collaboratory’s Health Care Systems Interactions Core, along with principal investigators conducting ePCT Demonstration Projects.

Topics include:

  • Anticipating changes that might impact intervention fidelity
  • Frameworks to assist in monitoring fidelity and adaptations
  • Strategies and case examples from the NIH Collaboratory Demonstration Projects
  • Pointers to additional resources

We encourage you to explore this new content.

 

March 17, 2020: Cheat Sheet on the Intraclass Correlation Coefficient

Posted on by Karen Staman

The NIH Collaboratory Biostatistics and Study Design Core has created an Intraclass Correlation Coefficient (ICC) Cheat Sheet to provide an introductory description of the ICC, which is important for the design and analysis of cluster-randomized trials.

“The intraclass correlation coefficient (ICC) is a descriptive statistic that describes the extent to which outcomes 1) within each cluster are likely to be similar or 2) between different clusters are likely to be different from each other, relative to outcomes from other clusters. The ICC is an important tool for cluster-randomized pragmatic trials because this value helps determine the sample size needed to detect a treatment effect.” —from the ICC Cheat Sheet

The tool is a 2-page handout that can be used in trainings or classes regarding pragmatic clinical trials involving cluster randomization.

For more on the ICC, see the Intraclass Correlation section in the Living Textbook or this in-depth working document on the ICC from the Biostatistics and Study Design Core. If you have questions, feedback or suggestions regarding this tool, please contact us at nih-collaboratory@dm.duke.edu.

March 12, 2020: Transforming Our Understanding of How to Conduct Research in a Real-World Setting

Posted on by Gina Uhlenbrauck

In a recent video interview, Dr. Helene Langevin, director of the National Center for Complementary and Integrative Health at the NIH, discusses the important work of the NIH Collaboratory in sharing knowledge and lessons learned as well as in harnessing expertise across the 19 Demonstration Projects it supports. “It is very important that we understand how research can be successfully implemented and tested in real-world clinical practice.”

 

 

For more interviews about the HEAL and PRISM projects, check out the February 21 news story.

March 6, 2020: Creating a Learning Health System Through Randomization (Leora Horwitz, MD, MHS)

Posted on by Gina Uhlenbrauck

Speaker

Leora Horwitz, MD, MHS
Associate Professor, Population Health and Medicine
Director, Center for Healthcare Innovation and Delivery Science, NYU Langone Health
Director, Division of Healthcare Delivery Science, Department of Population Health, NYU Grossman School of Medicine

Topic

Creating a Learning Health System Through Randomization

Keywords

Embedded research; Electronic health records; Randomization; Quality improvement (QI); Learning health systems

Key Points

  • Randomized QI projects are needed in order to know whether such system-level programs/interventions are effective.
  • The best candidates for QI randomization projects have a high volume of cases and short-term outcomes that are already being collected.
  • These randomized QI projects were developed in collaboration with the frontline care providers and staff to ensure seamless implementation with no additional burden. Also essential was buy-in from senior-level administration.

Discussion Themes

Statistical significance is not always the right threshold for decision making in a health system.

What amount of resources are needed to do these projects (eg, researcher/analysts, project managers)? Is the work self-sustaining?

Disappointing QI findings are important to know, so that ineffective activities can be discontinued.

Read more about this project in Creating a Learning Health System through Rapid-Cycle, Randomized Testing (Horwitz et al., New Engl J Med, Sep 2019).

Tags
#pctGR, @Collaboratory1

March 10, 2020: Supporting the New PRISM NIH Collaboratory Trials Addressing Pain Management Within Care Delivery

Posted on by Gina Uhlenbrauck

In a new video interview, Dr. Lesley Curtis, chair of the NIH Collaboratory Steering Committee, describes the importance of the four PRISM NIH Collaboratory Trials, which are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments. “We are particularly excited about the answers that will come out of these trials,” she says. Now in their UG3 planning year, the PRISM investigators are strongly encouraged to take full advantage of the Collaboratory’s resources, such as the significant expertise found across the Core Working Groups.

 

 

For more interviews about the HEAL and PRISM projects, check out the February 21 news story.

February 28, 2020: Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Posted on by Gina Uhlenbrauck

Speakers

Vincent Mor, PhD
Florence Pirce Grant University Professor
Department of Health Services Policy & Practice
Brown University School of Public Health

Leah Tuzzio, MPH
Research Associate
Kaiser Permanente Washington Health Research Institute

Jeffrey (Jerry) G. Jarvik MD MPH
Professor, Radiology, Neurological Surgery and Health Services
Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine
University of Washington

Topic

Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Keywords

Embedded research; Implementation; Healthcare systems; Nursing homes; Radiology reports; Electronic health records; Data collection; Pragmatic clinical trials

Key Points

  • Early engagement between study teams and health system leaders and staff can help ease the embedded intervention into the clinical workflow. Consider, for example, who will deliver the intervention and how difficult it will be to implement.
  • In the pilot phase, show that you can implement the intervention effectively. For example, demonstrate that you can collect the outcome data you will need within the pilot’s time frame. Ensure that your study questions are important to the partner healthcare system.

Discussion Themes

It is essential to anticipate, identify, and make a plan to address changes in the healthcare system as your trial is being conducted.

Among the NIH Collaboratory Trials, many have good measures of how much site-to-site variation there is, which helps to understand what the preconditions are for high levels of implementation.

Use the pilot study to maximize acceptability, maintain affordability, and consider the scalability of the intervention.

These topics and more are on the Living Textbook of Pragmatic Clinical Trials. Plan to hear the next topics in the Living Textbook Grand Rounds series.

Tags
#pctGR, @Collaboratory1

February 28, 2020: Meeting Minutes from NIH Collaboratory’s Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the UG3 PRISM NIH Collaboratory Trials. These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel as well as some IRBs responsible for oversight of the projects.

February 21, 2020: Nudge Study Updates (Michael Ho, MD, PhD; Sheana Bull, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Michael Ho, MD, PhD
Professor of Medicine, University of Colorado School of Medicine
Staff Cardiologist, Rocky Mountain Regional VA Medical Center

Sheana Bull, PhD, MPH
Professor, Colorado School of Public Health
Director, mHealth Impact Laboratory

Topic

Nudge Study Updates

Keywords

Cardiovascular health; Behavioral nudges; Disease self-management; Pharmacy data; Text messaging; mHealth; Medication adherence; Choice architecture

Key Points

  • Up to 50% of patients do not take their cardiovascular medications as prescribed. Nonadherence is associated with increased cardiovascular events.
  • Nudges prompt small, incremental changes in behavior and can be delivered through text messaging.
  • The Nudge pragmatic study was piloted across 3 integrated healthcare systems. The intervention uses pharmacy data to monitor gaps in patients’ cardiovascular medication refills. Patients with gaps receive text messages on their mobile phone to remind them to refill their medication.

Discussion Themes

A “chatbot” is used in one of the study arms to interact with the patient through the mobile phone application. As part of the analytic plan, the study team will be evaluating engagement with the interactive chatbot and the dose response.

The Nudge study gives patients two opportunities to opt out of participating. The study team is tracking demographics of patients who opted out as well as their reasons for opting out.

How do you handle the roughly 10% of people who receive care from more than one health system? That is, patients may be receiving conflicting advice, including directions to discontinue their medications.

Learn more about the Nudge NIH Collaboratory Trial.

Tags
#pctGR, @Collaboratory1

February 24, 2020: Study Snapshots for Six UH3 NIH Collaboratory Trials Are Available

Posted on by Gina Uhlenbrauck

Want to know more about the goals and challenges of the NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from these innovative pragmatic clinical trials.

Study Snapshots are accessible from each NIH Collaboratory Trial page and the links below:

  • ACP PEACE: Improving Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
  • EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder
  • GGC4H: Guiding Good Choices for Health: Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems
  • HiLo: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
  • Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
  • PRIM-ER: Primary Palliative Care for Emergency Medicine

February 21, 2020: New Video Interviews Highlight Goals of the NIH HEAL Initiative and PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this program, the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials present exciting new possibilities for answering important questions along with unique challenges.

Drs. Rebecca Baker and Wendy Weber discuss the aims of the HEAL Initiative, including:

  • Leveraging expertise across all NIH institutes and centers to enhance pain management and improve prevention and treatment strategies for opioid use disorder and addiction
  • Generating evidence to help clinicians and patients make the right treatment decisions

 

Drs. Meyers, Hernandez, and Weber discuss aspects of collaborating with the four PRISM NIH Collaboratory Trials, including:

  • Leveraging broad expertise in the Collaboratory program to support embedded healthcare systems research in pain management
  • Developing new understanding across different care models such as physical therapy, surgery, acupuncture therapy, and primary care settings
  • Learning about patient-reported outcomes that will be the most meaningful to establish best practices in pain management

Learn more about the PRISM NIH Collaboratory Trials on their webpages:

  • AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
  • OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting